Table 1.
Demographic and clinical characteristics of the UC cohort at baseline.
| Demographics and clinical characteristics | Overall cohort |
|---|---|
| Age (year) | |
| Median (IQR) | 47.0 (23.0) |
| Sex, n (%) | |
| Male | 67 (63.8) |
| Female | 38 (36.2) |
| BMI (kg/m2) | |
| Median (IQR) | 21.4 (4.3) |
| Smoking status – n (%) | |
| Current smoker | 4 (3.8) |
| Former smoker | 31 (29.5) |
| Never smoked | 62 (59.0) |
| Unknown | 8 (7.6) |
| Family history, n (%) | |
| Ulcerative colitis | 3 (2.9) |
| Sibling(s) | 2 (1.9) |
| Parent(s) | 1 (1.0) |
| Comorbidities, n (%) | |
| Hypertension | 5 (4.8) |
| Diabetes mellitus | 2 (1.9) |
| Autoimmune hepatitis | 1 (1.0) |
| Rheumatoid arthritis | 1 (1.0) |
| Categorical duration of UC, n (%) | |
| <1 year | 3 (2.9) |
| ⩾1–<3 years | 22 (21.0) |
| ⩾3–<7 years | 30 (28.6) |
| ⩾7 years | 13 (12.4) |
| Unknown | 37 (35.2) |
| Disease extent, n (%) (up to a week before or at baseline) | |
| Proctosigmoiditis | 24 (22.9) |
| Left-sided colitis | 22 (21.0) |
| Extensive colitis | 2 (1.9) |
| Pancolitis | 49 (46.7) |
| Unknown | 8 (7.62) |
| Partial Mayo score at baseline | |
| Median (IQR) | 6.0 (2.0) |
| Unknown (%) | 4 (3.8) |
| Full Mayo score at baseline | |
| Median (IQR) | 9.0 (2.0) |
| Unknown (%) | 10 (9.5) |
| Extraintestinal manifestations, n (%) (up to 12 months before or at baseline) | |
| Yes | 6 (5.7) |
| No | 99 (94.3) |
| Prior medications n (%) | |
| Anti-TNFs | 105 (100.0) |
| Infliximab | 71 (67.6) ¥ |
| Adalimumab | 55 (52.4) ¥ |
| Golimumab | 20 (19.0) ¥ |
| Aminosalicylates | 93 (88.6) |
| Corticosteroids | 71 (67.6) |
| Immunosuppressants * | 56 (53.3) |
| Antibiotics | 21 (20.0) |
| Probiotics | 3 (2.9) |
| Opioids | 1 (1.0) |
| Duration of prior anti-TNF therapy (months) | |
| Median (IQR) | 8.4 (16.7) |
| Number of prior anti-TNF therapy, n (%) | |
| One (1) prior anti-TNF | 72 (68.6) |
| Two (2) prior anti-TNFs | 25 (23.8) |
| Three (3) prior anti-TNFs | 8 (7.6) |
| Type of prior anti-TNF failure + , n (%) | |
| Inadequate response | 53 (50.5) |
| Loss of response | 32 (30.5) |
| Intolerance | 10 (9.5) |
| Unknown | 10 (9.5) |
| Concomitant medications for UC, n (%) | |
| Corticosteroids only | 14 (13.3) |
| Immunosuppressants only | 6 (5.7) |
| Corticosteroids and immunosuppressants | 5 (4.8) |
| No corticosteroids or immunosuppressants | 80 (76.2) |
Sum to more than 100% due to more than one use.
Immunosuppressants considered are azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, and thalidomide.
Data captured as free-text initially and subsequently coded manually into the four categories. Entries such as ‘dampened responsiveness’, ‘primary non-response’, ‘no response’, and ‘no effect’ were coded as inadequate responses. Entries such as ‘secondary loss of response’, ‘recurrence of symptoms’, and ‘loss of response’ were coded as a loss of response. Entries such as ‘cytomegalovirus infection’, ‘hypotension’, and ‘intolerance’ were coded as intolerance. Other free-text entries such as ‘principal investigator’s judgement’ and ‘drug change’ etc. were considered as unknowns.
BMI, body mass index; IQR, interquartile range; SD, standard deviation; TNF, tumor necrosis factor; UC, ulcerative colitis.